MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 382-10

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "column passed pre-use check, but when placed on patient vent alarmed and showed 95% leak.Once column was changed leak came down to 5% and patient has been on vent since." no patient injury or consequence.

Manufacturer Narrative

(b)(4).Received one (1) 382-10 universal concha column for investigation.Upon receipt the column was visually inspected for any signs of abuse/misuse/damage.No defects were noted.Pressure decay testing and column functional testing were performed and the sample failed both tests.The device history record of lot number 74c1900444 was reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the functional inspection of the sample received, the complaint is confirmed.A non-conformance was opened in order to address the root cause and action plan for the reported issue.Personnel of the assembly line will be notified for awareness.

Event Description

The complaint is reported as: "column passed preuse check, but when placed on patient vent alarmed and showed 95% leak.Once column was changed leak came down to 5% and patient has been on vent since." no patient injury or consequence.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8776939
• MDR Text Key: 150589650
• Report Number: 3004365956-2019-00183
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K141940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 382-10
• Device Lot Number: 74C1900444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERVO-N VENTILATOR; SERVO-N VENTILATOR; SERVO-N VENTILATOR